FDA Adverse Event
Malfunction
Summary report: N
CAD II
MDR report key: 3142585
·
Received June 3, 2013
Report
- Report Number
- 8030965-2013-02599
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- April 12, 2013
- Report Date
- May 9, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS NOTED ON (B)(6) 2013 THAT THE RETURN STOP OF THE COMPACT AIR DRIVE (CAD) II IS DEFECTIVE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243794 | CAD II | HWE | SYNTHES GMBH | 32243 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |